Antithrombogenic, non-calcifying material and method of making articles for medical purposes

• US 4,996,054 A
• Filed: 10/19/1988
• Issued: 02/26/1991
• Est. Priority Date: 11/23/1985
• Status: Expired due to Fees

• Current Assignee: Beiersdorf AG (maxingvest GmbH & Co. KGaA)
• Original Assignee: Beiersdorf AG (maxingvest GmbH & Co. KGaA)
• Inventors: Holtzmann, Hans-Joachim, Reul, Helmut, Pietsch, Hanns, Kartheus, Holger, Sachau, Gunther
• Primary Examiner(s): Page, Thurman K.
• Application Number:
  US07/240,998
• Time in Patent Office: 860 Days
• Field of Search: 523/112, 424/105, 424/405, 424/409, 424/422, 424/423, 424/484, 424/78, 623/1, 623/2, 623/3, 623/12, 623/24, 623/11
• US Class Current: 424/422
• CPC Class Codes: A61F 2/24 Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• CPC Class Codes: A61L 27/02 Inorganic materials
• CPC Class Codes: A61L 27/18 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: A61L 27/507 for artificial blood vessels apparatus for applying cells on a blood vessel prosthesis A61F2/062
• CPC Class Codes: A61L 33/0005 Use of materials characterised by their function or physical properties
• CPC Class Codes: A61L 33/068 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds A61L33/062 takes precedence
• CPC Class Codes: B29C 41/14 Dipping a core B29C41/10 takes precedence
• CPC Class Codes: B29C 41/20 incorporating preformed parts or layers, e.g. moulding inserts or for coating articles
• CPC Class Codes: B29C 67/246 Moulding high reactive monomers or prepolymers, e.g. by reaction injection moulding [RIM], liquid injection moulding [LIM] casting monomers B29C39/006, mixing construction B29B7/74
• CPC Class Codes: B29C 70/68 by incorporating or moulding on preformed parts, e.g. inserts or layers , e.g. foam blocks mould constructions therefor B29C33/12; joining preformed parts by moulding B29C65/70
• CPC Class Codes: B29K 2083/005 LSR, i.e. liquid silicone rubbers, or derivatives thereof
• CPC Class Codes: C08L 75/04 Polyurethanes
• CPC Class Codes: Y10S 623/90 Stent for heart valve

Abstract

An antithrombogenic, non-calcifying, and elastic material on a basis of polyurethane, characterized by the addition of fatty-acid esters and optionally by the further addition of cross-linking agents that react with water.

Claims

1. A method of forming a shaped article comprising shaping a composition comprising a polyurethane, a fatty acid ester and, as a cross-linking agent, an alkoxysilyl compound that contains at least two methoxysilyl, ethoxysilyl, propoxysilyl, or butoxysilyl groups and at least one amino group, and thereafter cross-linking the shaped mass through the action of water or humidity.

2. A method according to claim 1, wherein the cross-linking agent is present in about 0.1 to 5% by weight of the polyurethane.

3. A method according to claim 1, wherein the fatty acid ester is an ester of an aliphatic, unbranched, saturated, or singly or doubly unsaturated monocarboxylic acid with 10 to 20 carbon atoms and a monovalent or polyvalent aliphatic alcohol with 1 to 6 carbon atoms or ascorbic acid, a polyoxyethylene fatty-acid ester, or a polyoxyethylene-sorbitane fatty-acid ester and is present in about 0.1 to 10% by weight of the polyurethane, and the polyurethane is a linear, segmented polyether-urethane urea or a linear, segmented polyester-urethane urea.

4. The method according to claim 3, wherein the ester is present in about 0.5 to 5% by weight of the polyurethane.

6. The device produced by the method of claim 1.

5. A shaped structure formed of a composition consisting essentially of a polyurethane, a fatty acid ester and an alkoxysilyl cross-linking agent which contains at least two methoxysilyl, ethoxysilyl, propoxysilyl or butoxysilyl groups and at least one amino group, the cross-linking agent being present in about 0.1 to 5% by weight of the polyurethane, the device produced therefrom being antithrombogenic, non-calcifying and elastic.

7. A shaped structure which in use comes into contact with blood, and which is formed by cross-linking a composition comprising a polyurethane, a fatty-acid ester and a cross-linking agent, the structure being antithromobogenic, non-calcifying and elastic.

8. A shaped structure according to claim 7, wherein the structure is a cardiac valve, blood pump, a membrane, a coating on a cardiac-pacemaker electrode, an angiographic or cardiac cathether, an artificial pericardium, or a tube, valve or bag that comes into contact with blood.

9. A shaped structure which in use comes into contact with blood, and which is formed of a composition comprising a polyurethane and a fatty acid ester, the structure being antithromobogenic, non-calcifying and elastic.

10. An antithrombogenic, non-calcifying and elastic cardiac valve, blood pump, membrane, coating on a cardiac-pacemaker electrode, angiographic or cardiac catheter, artificial pericardium, or tube, valve or bag that comes into contact with blood, produced by cross-linking a composition according to claim 9.

11. A shaped structure according to claim 9, wherein the structure is a membrane, an angiographic or cardiac catheter, or a tube, valve, bag or blood pump that in use comes into contact with blood.